Vitalith S 3000 Series
by Vitatron Medical BV 510(k)
Active
510(k) K790666
Overview
The Vitalith S 3000 Series is an Implantable Pacemaker Pulse-Generator, a Class 3 cardiovascular device designed to regulate heart rhythm by delivering electrical impulses to the heart when necessary. It is intended for patients requiring permanent pacing to treat bradycardia or other conduction disorders, ensuring consistent cardiac output and stability.
This device is supplied as a reusable, implantable medical device and is regulated under FDA 510(k) clearance (K790666) with a Substantially Equivalent determination. Manufactured by Vitatron Medical BV, it adheres to Regulation 870.3610 and is classified under product code DXY. No additional sterility, MRI safety, or single-use specifications are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790666 | Date1 Jun 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vitatron Medical BV
Questions
What is the primary clinical purpose of the Vitalith S 3000 Series implantable pacemaker, and how does it achieve this?
The Vitalith S 3000 Series is designed to regulate heart rhythm by delivering electrical impulses to the heart when needed, primarily for patients with bradycardia or conduction disorders. It ensures consistent cardiac output and stability by continuously monitoring and pacing the heart as required, helping maintain normal heart function in patients who rely on permanent pacing.
Is the Vitalith S 3000 Series intended for single-use or can it be reused after implantation?
The Vitalith S 3000 Series is explicitly described as a *reusable* implantable medical device. Since it is intended for permanent implantation, it is not designed for single-use and is meant to remain in place long-term, with potential for replacement only when clinically necessary.
What regulatory pathway was followed for FDA clearance of the Vitalith S 3000 Series, and what does this mean for its use?
The device received FDA clearance through a Traditional 510(k) process with a Substantially Equivalent (SESE) determination, filed under product code DXY and reviewed by the Cardiovascular (CV) Advisory Committee. This means the FDA determined it is as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in treating bradycardia or conduction disorders.
Are there any specific storage requirements mentioned for the Vitalith S 3000 Series before implantation?
The provided regulatory data does not specify any unique storage requirements beyond standard practices for implantable medical devices. Since it is reusable and intended for permanent implantation, it should be stored in a clean, dry environment following manufacturer guidelines to maintain sterility and functionality until use.